FDA Inspection 720860 — Rangen, LLC
The FDA completed an inspection of Rangen, LLC on April 4, 2011 in Buhl, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 4, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Buhl, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1811 | 21 CFR 225.58(b)(1) | Three assays per year |
| 1925 | 21 CFR 225.65(b)(2) | Flush material handling |
| 1930 | 21 CFR 225.65(b)(3) | Sequential production |
| 2189 | 21 CFR 225.110(b)(1) | Distribution record elements |
| 4555 | 21 CFR 225.142 | Use in accord with directions |